Proesmans 2013.
| Methods | RCT. Parallel design. Duration: 3 months. Single centre based in Europe. |
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| Participants | 58 children with CF, all with new isolation of P aeruginosa (sputum or cough swabs). Age: median age 9 years, interquartile range (4.7 ‐ 13.1 years). Gender: 31 male, 27 female. Lung function: median FEV₁ at inclusion 98% predicted. |
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| Interventions | Treatment (n = 29): Inhaled TSI (300 mg 2x daily for 28 days). Control (n = 29): 3 months combination therapy with inhaled colistin (2 MU 2x daily) + oral ciprofloxacin (10 mg/kg 3x daily). |
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| Outcomes | Primary outcomes Eradication of P aeruginosa at the end of treatment. Secondary outcomes Time to P aeruginosa relapse; antibodies (Ab); IgG; FEV₁; BMI; and P aeruginosa status at 2‐year follow up. | |
| Notes | Participants were then switched to the other arm or treated with IV antibiotics if clinically indicated. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomised in blocks of 10. No description given of method of randomisation, nor of any stratification. |
| Allocation concealment (selection bias) | Unclear risk | Did not report how allocation was concealed. |
| Blinding (performance bias and detection bias) All outcomes | High risk | Blinding not possible for participants and clinicians as treatments compared were inhaled versus inhaled and oral. No details regarding whether outcome assessors were blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis on all 58 randomised participants. |
| Selective reporting (reporting bias) | High risk | Protocol published on ClinicalTrials.gov (identifier: NCT01400750). All pre‐specified outcomes reported. BMI z score, weight z score and frequency of exacerbations were reported not to have changed significantly for trial participants, but numerical data are not reported. |
| Other bias | Unclear risk | Primary outcome was assessed at end of treatment which was different for the 2 treatment groups 28 days for TSI participants versus 3 months for colistin/ciprofloxacin participants. |